LONDON, Nov. 19, 2019 /PRNewswire/ -- Smith+Nephew (LSE:
SN, NYSE: SNN), the global medical technology business, today
announces a new clinical study illustrating the successful
treatment of large (3-5cm) and massive (5cm+) rotator cuff tears
using its REGENETEN Bioinductive Implant.1
Repairs of large and massive rotator cuff tears are recognised
as having a high rate of failure, with more than 40% requiring
further treatment2-4. The prospective, non-comparative
arm study of the REGENETEN implant in 23 patients with large and
massive tears in the US, published in the American Journal of
Sports Medicine, demonstrated a 96% tendon healing rate at two
years. There was no significant difference in treatment
success between primary repairs and revision surgery.
"This study provides further insight into the success of the
REGENETEN Bioinductive Implant," said Michael O'Brien MD, Associate Professor of
Clinical Orthopaedics, Tulane
University School of Medicine, New
Orleans, LA. "It is the latest addition to the growing body
of evidence supporting REGENETEN as an effective treatment option
that now covers the entire spectrum of tears from partial to large
and massive tears."
The collagen-based REGENETEN Bioinductive Implant stimulates the
body's natural healing response by inducing the growth of new
tendon-like tissue to biologically augment the existing tendon and
disrupt disease progression5-7. The REGENETEN implant,
delivered arthroscopically through a small incision over the
location of the rotator cuff tendon injury, is about the size of a
postage stamp and is gradually absorbed within 6
months.7*
Tendon healing was assessed by serial ultrasound examinations to
24 months and a single post-operative MRI. Tendon thickness
increased from 3 months to 12 months before slightly decreasing at
24 months, representing functional remodelling of the new tissue.
No implant-related adverse events occurred.1
The REGENETEN implant's efficacy in patients with
partial-thickness and small full-thickness tears is well-known with
data showing rapid and sustained healing including a reduced tear
size in 94% of partial-thickness tear patients5 and no
re-tears at 24 months in small full-thickness
tears.8
"REGENETEN is the first solution of its kind to treat large and
massive thickness rotator cuff tears," said Vasant Padmanabhan, President of R&D,
Smith+Nephew. "More than 650,000 rotator cuff procedures take place
annually in the US, potentially growing at a rate of 5-6% each
year. This data reinforces our confidence that this revolutionary
technology is truly a game-changer in the treatment of patients
with rotator cuff disease."
The REGENETEN Bioinductive Implant is currently available in
the United States.
|
*based on in
vivo testing
|
References
- Thon SG, O'Malley L, O'Brien MJ, Savoie FH. Evaluation of
healing rates and safety with a bioinductive collagen patch for
large and massive rotator cuff tears: 2-year safety and clinical
outcomes. Am J Sports Med. 2019 May 31. [Epub ahead of
print].
- Bishop J, Klepps S, Lo IK, Bird J, Gladstone JN, Flatow EL.
Cuff integrity after arthroscopic versus open rotator cuff repair:
A prospective study. J Shoulder Elbow Surg.
2006;15(3):290-299.
- Heuberer PR, Smolen D, Pauzenberger
L et al. Longitudinal long-term
magnetic resonance imaging and
clinical follow-up after single-row
arthroscopic rotator cuff repair. Am
J Sports Med. 2017;45(6):1283-1288.
- Henry P, Wasserstein D, Park S, et al. Arthroscopic
repair for chronic massive rotator cuff tears: A systematic review.
Arthroscopy. 2015;31(12):2472-80.
- Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP.
Radiologic and clinical evaluation of a bioabsorbable collagen
implant to treat partial-thickness tears: a prospective multicenter
study. J Shoulder Elbow Surg. 2017.
- Bokor DJ, Sonnabend D, Deady L et al. Evidence of healing of
partial-thickness rotator cuff tears following arthroscopic
augmentation with a collagen implant: a 2-year MRI follow-up. MLTJ.
2016;6(1):16-25.
- Van Kampen C, et al.
Tissue-engineered augmentation of a rotator cuff tendon using a
reconstituted collagen scaffold: A histological evaluation in
sheep. MLTJ. 2013;3:229-235.
- Bokor DJ, Sonnabend D, Deady L, et al. Preliminary
investigation of a biological augmentation of rotator cuff repairs
using a collagen implant: a 2-year MRI follow-up. Muscles Ligaments
Tendons J. 2015;5(3):144-150.
About Smith+Nephew
Smith+Nephew is a portfolio medical
technology business that exists to restore people's bodies and
their self-belief by using technology to take the limits off
living. We call this purpose 'Life Unlimited'. Our 16,000+
employees deliver this mission every day, making a difference to
patients' lives through the excellence of our product
portfolio, and the invention and application of new technologies
across our three global franchises of Orthopaedics, Advanced
Wound Management and Sports Medicine & ENT. Founded in
Hull, UK, in 1856, we now operate
in more than 100 countries, and generated annual sales of
$4.9 billion in 2018. Smith+Nephew is
a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms 'Group'
and 'Smith+Nephew' are used to refer to Smith & Nephew
plc and its consolidated subsidiaries, unless the context
requires otherwise.
For more information about Smith+Nephew, please visit
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